FDA recall record · openFDA

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

6 FDA recalls on record (2023–2025) — 6 device. 6 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switch 2

Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required 1

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous moveme 1

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially r 1

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no functi 1

Recalls

Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems T Class II 2025-10-16 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina Class II 2024-09-06 Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin Class II 2024-09-06 The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studie Class II 2024-09-06 Shimadzu, Trinias, Digital Angiography System Class II 2024-01-29 Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 Class II 2023-04-10

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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